drugset / Trial / NCT02628860
Efficacy of Ferric Carboxymaltose (Ferinject®) in Anemic Patients Anticipating Pancreatoduodenectomy
NaSingle-groupOpen-labelTreatment
Summary
This phase II study is to evaluate the safety and efficacy of Ferinject® in reducing perioperative transfusion in iron deficiency anemia patients anticipating pancreatoduodenectomy.
Timeline
- Start
- 2014-01
- Primary completion
- 2020-04-27
- Completion
- 2020-04-27
Publications
- Results Park SJ, Kim SW, Jang JY, Lee KU, Park YH. Intraoperative transfusion: is it a real prognostic factor of periampullary cancer following pancreatoduodenectomy? World J Surg. 2002 Apr;26(4):487-92. doi: 10.1007/s00268-001-0254-6. Epub 2002 Feb 4.
- Results Yeh JJ, Gonen M, Tomlinson JS, Idrees K, Brennan MF, Fong Y. Effect of blood transfusion on outcome after pancreaticoduodenectomy for exocrine tumour of the pancreas. Br J Surg. 2007 Apr;94(4):466-72. doi: 10.1002/bjs.5488.
- Results Peters JH, Carey LC. Historical review of pancreaticoduodenectomy. Am J Surg. 1991 Feb;161(2):219-25. doi: 10.1016/0002-9610(91)91134-5.
- Results Kaplan J, Sarnaik S, Gitlin J, Lusher J. Diminished helper/suppressor lymphocyte ratios and natural killer activity in recipients of repeated blood transfusions. Blood. 1984 Jul;64(1):308-10.
- Results Waymack JP, Gallon L, Barcelli U, Trocki O, Alexander JW. Effect of blood transfusions on immune function. III. Alterations in macrophage arachidonic acid metabolism. Arch Surg. 1987 Jan;122(1):56-60. doi: 10.1001/archsurg.1987.01400130062009.
- Results Innerhofer P, Tilz G, Fuchs D, Luz G, Hobisch-Hagen P, Schobersberger W, Nussbaumer W, Lochs A, Irschick E. Immunologic changes after transfusion of autologous or allogeneic buffy coat-poor versus WBC-reduced blood transfusions in patients undergoing arthroplasty. II. Activation of T cells, macrophages, and cell-mediated lympholysis. Transfusion. 2000 Jul;40(7):821-7. doi: 10.1046/j.1537-2995.2000.40070821.x.
- Results Ghio M, Contini P, Mazzei C, Brenci S, Barberis G, Filaci G, Indiveri F, Puppo F. Soluble HLA class I, HLA class II, and Fas ligand in blood components: a possible key to explain the immunomodulatory effects of allogeneic blood transfusions. Blood. 1999 Mar 1;93(5):1770-7.
- Results Burrows L, Tartter P. Effect of blood transfusions on colonic malignancy recurrent rate. Lancet. 1982 Sep 18;2(8299):662. doi: 10.1016/s0140-6736(82)92764-7. No abstract available.
- Results Griffin JF, Smalley SR, Jewell W, Paradelo JC, Reymond RD, Hassanein RE, Evans RG. Patterns of failure after curative resection of pancreatic carcinoma. Cancer. 1990 Jul 1;66(1):56-61. doi: 10.1002/1097-0142(19900701)66:13.0.co;2-6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ferric carboxymaltose | Other / unclassified | 500 mg | Intravenous |
| Subject | Ferric carboxymaltose | Other / unclassified | 1000 mg | Intravenous |